The American Association of Tissue Banks (AATB) published its first standards in 1984. The FDA final rule on current Good Tissue Practices (cGTP) became effective in May 2005. AlloSource strives to continuously improve processing procedures and facilities that not only comply with, but exceed, industry standards and regulations.
Surgeons and procurement specialists should investigate potential tissue providers to ensure the needs of the patient are met. For example, many allograft providers employ aseptic techniques to clean the tissue they process. Several use terminal sterilization as well. This is an important distinction, as appropriate levels of sterilization go further in reducing bioburden than even the most stringent disinfecting processes.
Use this checklist when comparing potential allograft suppliers to evaluate and ensure that allografts have been recovered and processed to the highest standards available in the industry today and that you receive the quality, expert service you demand.
Allograft processing and supply is primary business?
YES NO
Experienced, industry-accredited recovery partners?
YES NO
Aseptic processing and terminal sterilization to a SAL of 10-6?
YES NO
Validated cleaning processes?
YES NO
Testing laboratory is CLIA-registered?
YES NO
Processing facility is AATB accredited and FDA current Good Tissue Practices (cGTP) compliant?
YES NO
The organization has internal physician oversight built-in?
YES NO
Broad product line with availability of customized grafts?
YES NO
Reputation for high level of dimensional accuracy?
YES NO
Processes that ensure premium levels of allograft quality?
YES NO
Robust tissue inventory and tracking systems?
YES NO
Expert counsel available to ensure allograft matches specs?
YES NO
Strong partners and carefully chosen alliances?
YES NO
Patient and donor-focused organizational purpose?
YES NO
